Production will support development plans and initial commercial needs.
Oncolytics Biotech reports successfully transferred cGMP production for its cancer drug candidate at the 40-liter batch size to SAFC Pharma. The compound Reolysin is in multiple clinical programs in different cancer types.
Yields at the 40-litre scale should provide sufficient doses to support future development plans leading to registration and the anticipated early-stage commercial requirements, notes Oncolytics. Development work to support further scale-up to the 100-litre level is currently under way.
“Consistent with our previous announcement of a $12 million expansion of capacity, we will be in a position to support commercial production of Reolysin,” says Jeffrey L. Strobel, Ph.D., site director at SAFC Pharma’s operation in Carlsbad, CA. The Carlsbad facility supports the viral vector and vaccine community with its process development and analytical laboratory expertise as well as its cGMP capability, he adds.